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A Clinical Evaluation of the HYDRA Self Expanding Transcatheter Aortic Valve

Aortic Valve Stenosis Clinical Trial

Official title:
A Clinical Evaluation of the HYDRA Self Expanding Transcatheter Aortic Valve

Clinical Trial Summary

The purpose of this study is the evaluation of the performance, safety and efficacy of Hydra Aortic valve in real-world patients. Following initial implantation, all patients will have clinical follow up at 30 days, 3, months, 6 months and 12 months

Clinical Trial Description

This study is a multicenter, prospective, non-randomized investigational study designed to assess the safety and performance of the HYDRA Aortic valve and delivery system. Primary endpoint for safety is the 30 day all cause mortality rate. Primary endpoint for performance is the acute device success. In addition, the efficacy of the HYDRA Aortic valve and delivery system will be evaluated. Up to 165 patients will be enrolled in the study in order to achieve 150 subjects successfully implanted. All patients will have a clinical follow-up at 30 days, 3months, 6 months and 12 months post implant. The follow-up procedure table is shown in Appendix A. The patient is enrolled in the study as a subject only upon signature of the informed consent. All subjects will be reviewed by the Principal Investigator prior to undergoing the implant procedure for the Hydra Aortic Heart Valve. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02434263
Study type Interventional
Source Vascular Innovations Co. Ltd.
Contact
Status Active, not recruiting
Phase N/A
Start date August 13, 2015
Completion date July 2025
View Details
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